The present study is a randomized clinical trial (RCT). Convenience sampling conducts among clients who refer to public and private clinics of addiction treatment in Rasht city, Iran. After random selection, samples will be divided into two groups including case (intervention) group and control group and these groups will adjusted based on the demographic variables. Then, participants in case group, beside routine interventions that conduct in clinics, will attend in the cognitive behavioral group consulting sessions. Moreover, routine interventions of clinic will be done in control group. Group consulting will be hold by attending maximum number of 12 to 15 clients in each group for six sessions and one session per week that takes about 50 to 70 minutes. Before starting interventions, clients in both groups will complete the self-efficacy scale questionnaire of Bramson and self-perception scale questionnaire of Dr. Poorhouse. Moreover, 4 weeks after the last consulting session for each group, questionnaire will be filled by clients of both groups again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061626844N3
Registration date:2016-07-26, 1395/05/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-26, 1395/05/05
Registrant information
Name
Amir Jalali
Name of organization / entity
Kermanshah University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 0083
Email address
a_jalali@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group cognitive behavioral counseling on the self-efficacy and self-perception among methadone maintenance treatment clients.
Public title
The effect of counseling on the self-efficacy and self-perception among methadone maintenance treatment clients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: all clients in public and private centers (in the first stage of sampling) that: the age range is 18 to 65 years; the patient would have desire and ability to attend the consulting sessions; drug use is at least 6 months; at least 1 month of treatment with methadone is past; the patient must not have attend in another similar program; the patient must not have history of mental illness; the patient must have the ability of reading and writing; the patient must not have some abnormalities including mental retardation and physical disability such as deafness and blindness.
Exclusion criteria: refusal to continue cooperation; no presence in more than one session; discontinue the methadone treatment during investigation.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shaheid Beheshti
City
Kermanshah
Postal code
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
IR.KUMS.REC.1395.219
Health conditions studied
1
Description of health condition studied
Substance use disorder
ICD-10 code
F10, F11
ICD-10 code description
Mental and behavioural disorders due to use of alcohol, opioids
Primary outcomes
1
Description
Self efficacy
Timepoint
Before and four weeks after of final session of intervention
Method of measurement
Bramson self efficacy scale
2
Description
Self perception
Timepoint
Before and four weeks after of final session of intervention
Method of measurement
Pour Hossein self perception scale
Secondary outcomes
empty
Intervention groups
1
Description
Cognitive behavioral counselling for Intervention group
Category
Lifestyle
2
Description
Custom intervention due treatment center for control group
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Punlic and Private Centers for Methadone Therapy in Rasht city
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences, Research deputy
Full name of responsible person
Kourosh Hamzehee
Street address
Research deputy, Kermanshah University of Medical Sciences, Shaheid Beheshti Blvd.
City
Kermabshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences, Research deputy
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behnam Khaledi
Position
MSc, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 3826 0083
Fax
Email
bkhaledi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Jalali
Position
PhD
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 3826 0083
Fax
Email
a_jalali@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Naseibeh Elahei Poshteh Roudi
Position
Master Student of Psychiatric Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3826 1083
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)